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R&D Capabilities

Case Studies


The Opportunity
A young biotech firm had completed a Phase I trial, in which promising results for its oncology drug were being seen in a number of different tumor types. The company knew it was at a critical juncture, but was uncertain which direction it should pursue next.

The InClinica Difference
One of InClinica’s physicians had deep experience in developing oncology drugs, gained both as a sponsor and as a CRO. He modified both the protocol and the development plan to better match the market conditions for evolving oncology therapy. In particular, he recommended a different indication – that the biotech firm focus on pancreatic cancer, which would offer it an easier-to-recruit base of patients.

The Outcome
Because InClinica met its patient recruitment and enrollment goals, the biotech firm was able to reach Phase II proof of concept faster. It was approached by a global pharmaceutical firm with which it entered into a partnership.

 


The Opportunity
A small, private pharmaceutical company with a novel delivery method for an approved diabetes drug approached us. It was anxious to get patients enrolled so that it could get approval for its drug device combination. But the company was unsure about the best clinical sites to perform the study and needed to minimize costs.

The InClinica Difference
With its global footprint, InClinica was able to recommend alternative regions and sites around the world, with fewer competing trials, the ability to enroll patients faster, and options that were within budget.

The Outcome
After we identified the optimal sites for this company and its diabetes compound, the company successfully completed its trial, becoming part of the company’s global submission to regulatory authorities. The sponsor is optimistic that the package will be approved for marketing.

 


The Opportunity

Just as a biotech firm was about to receive approval for its analgesic therapy, it received pushback from regulatory authorities, seeking more detailed plans for specific subpopulations of patients—on a challenging deadline. The small company hadn’t previously encountered this type of request from a regulatory body and needed to identify clinicians and other experts to prepare the response.

The InClinica Difference
Within 24 hours, InClinica had connected the biotech firm with two of the nation’s leading experts in analgesia and pain syndromes. Together, they crafted a plan that met the stated regulatory requirements while identifying various conditions suitable for inclusion in the plan.

The Outcome
The regulatory body reviewed the plan and accepted its study outlines.